Actively Recruiting

Age: 1Day - 12Years
All Genders
ID05687292

Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children

Led by Boston Children's Hospital · Updated on 2026-05-12

330

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

T

The Brett Boyer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a clinical decision support system (CDSS) on children under 12 years old who are receiving mechanical ventilation after surgery for congenital heart disease (CHD). The study aims to see how the CDSS affects the length of time these children remain on mechanical ventilation. This is an observational, single-center study comparing patients using the CDSS with a historical group to determine if the system helps reduce ventilation duration. The CDSS is integrated into the T3 Visualization Platform, which collects and displays continuous data from the patient's monitors, ventilator, and lab results on a bedside computer updated every 5 seconds. It uses predictive algorithms to estimate risks related to heart output, ventilation, and acidosis. Medical teams review the CDSS recommendations twice daily during rounds to guide weaning and extubation decisions. If the clinical team chooses not to follow the CDSS advice, they provide reasons via a brief survey. Participants will be monitored from surgery up to 28 days afterward. Researchers will assess the duration of mechanical ventilation and track events such as unplanned extubations, use of noninvasive ventilation, reintubation within 48 hours of extubation, and how closely the clinical team follows CDSS recommendations. The study will collect data prospectively after starting the CDSS and compare it with retrospective data before its use.

CONDITIONS

Brief Title

Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children

Who Can Participate

Age: 1Day - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children younger than 12 years old
  • Have had cardiac surgery
  • Receiving mechanical ventilation for 48 hours or more in the Cardiac Intensive Care Unit following surgery
Not Eligible

You will not qualify if you...

  • Premature infants born before 37 weeks' gestation
  • Weigh less than 2 kilograms
  • Dependence on baseline ventilator via tracheostomy or noninvasive positive pressure ventilation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Twice daily screenings during morning and evening rounds

Implementation

Duration - Up to 28 days after cardiac surgery

Participants receiving mechanical ventilation will be monitored using a clinical decision support system (CDSS) integrated into the bedside T3 platform to inform ventilator weaning, extubation readiness assessments, and extubation decisions.

Twice daily reviews during clinical rounds

Long-term Monitoring

Duration - Up to 28 days after surgery

Participants are observed for outcomes such as duration of mechanical ventilation, unplanned extubation, reintubation, and use of noninvasive ventilation following extubation.

Monitoring during the 28 days post-surgery with assessments around extubation events

Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

D

Daniel L Hames, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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